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Amgen stops trial of Teneobio cancer candidate, taking $650M BiTE out of earnings
2023-10-31
临床1期并购临床2期抗体药物偶联物蛋白降解靶向嵌合体
The discontinuation of AMG 340 is the latest in a series of rethinks regarding bispecific T-cell engagers, BiTEs, for short.
Amgen’s Teneobio misadvAMG 340has taken a $650 million BiTE out of its earnings. The Big Biotech took the hit after stopping a phase 1 trial of the PSMA bispecific it picked up in the $900 million acquisition of Teneobio two years ago.
Amgeng TTeneobiogave Amgen control of AMG 340, a PSMAxCD3 bispecific designed to turnBig Biotechainst metastatic castrate-resistant prostate cancer PSMAPC). Amgen already had a PSMA bispecific, acapatamab, when iTeneobio Teneobio. The decision to double up reflected a belief that the drug candidates used “a different approach.” A little more than two years later, both approaches have been found wanting.
Amgen sTeneobioevelopAmgencapatamab inAMG 340mmer of 2022. AMG 340 hung on longer, but the ax was broumetastatic castrate-resistant prostate cancer (mCRPC)uaAmgenof a phase 1 doPSMAscalation stuacapatamabasset as part of Teneobioncial update for the third quarter.
Amgentatement lacks detaiacapatamabthinking behind the action but does contain information about how it will affect Amgen’s finances. Amgen took a $650 million net impairment charge in relation to the axing of AMG 340, dragging down its earnings per share.
The discontinuation of AMG 340 is the latest in a series of rethinks regarding bispecific T-cell engagers, or BiTEs Amgenhort. Amgen dAmgend candidates aimed at BCMA and PSMA last summer. Amid the changes, the biotech has remained committed to tarlatamab, a DLL3 therapy that recently impressed in a phase 2 trial. Amgen is testing tarlatamab in a form of prostate cancer and has another mCRPC project on the go.
Xaluritamig, a bispecifAMG 340 binds to STEAP1, is in phase 1b development in mCRPC. Amgen plans to start two more phase 1 triaAmgen the candidate in patients wiBCMAarly PSMAtate cancer. Paul Burton, M.D., Ph.D., chief medical officer at Amgen,tarlatamabtold Fierce Biotech how xaluritamig illustrates one of two apAmgenhes it can ttarlatamabidate oncologyprostate cancermCRPC
Xaluritamigere are two options. One is wSTEAP1go after cancer by cancer. We'remCRPCg Amgen We're looking at … xaluritamig in prostate. Where we see receptors that aearly prostate canceriety of different cancer cells, then I think we wouldAmgen go after a strategy of a basket trxaluritamig” Burton said.
Amgen disclosed the discontinuation of AMG 340 alongsidcancer thacancers stopping a phase 1b study of bemarituxaluritamiguamous non-small cell lung cancer with FGFR2b overexpression. The clinical trial wcancerluating the anti-FGFR2b antibody as a monotherapy and in combination with standard of care therapy. Amgen is continuing to study the candidate in a clutch of other phase 1 to phase 3 trials.
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